Notice to Stakeholders: Foreign Sites - Expiring; Change to Expiry Calculation

• 1) Renewing Foreign Sites that are Nearing Expiration
• 2) New: Changes to Calculation of Period of Validity/Expiry for Foreign Site Evidence

To: Drug Establishment Licence (DEL) Holders

Changes to the Food and Drug Regulations, that came into effect on April 01, 2011 removed the expiration date for a DEL. All DEL holders must submit applications for Annual Review with applicable fees, to be received by Health Canada before April 01 of each calendar year in order to avoid cancellation of their DELs. If an application for Annual Review with the required supporting information and fees is received by Health Canada before April 01, the DEL continues to be valid until such time as Health Canada completes a review and makes a decision on that application. The validity of foreign site evidence will, however, continue to have an expiry date.

In addition, a 250 day service standard was implemented for the review of all DEL applications, including new applications, applications for Annual Reviews and Amendments to existing DELs.

1) Renewing Foreign Sites that are Nearing Expiration

In order to maintain a valid foreign site, DEL holders must submit an application along with full and complete GMP evidence at least 250 days before the expiry of the foreign site.

Example: If a foreign site's evidence expires on.....

• July 8, 2013, an application should be received by Health Canada by October 31, 2012, in order to be processed and issued within the 250 day service standard.
• February 17, 2014, an application should be received by Health Canada by June 12, 2013, in order to be processed and issued within the 250 day service standard.

This application may be in the form of an Amendment to update the foreign site evidence or as part of the Annual Review application. Failure to submit an application at least 250 days in advance of the expiry of the foreign site or failure to submit full and complete GMP evidence with the application may result in the expiry of the foreign site.

For more information on what is considered full and complete GMP evidence, please consult the document entitled Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).

Please consult the website for more information on the annual review process.

DEL applications may be submitted electronically to: ELapplicationLE@hc-sc.gc.ca

If you have any questions regarding the DEL application process, contact the Establishment Licensing, Billing and Invoicing Unit (ELBIU) at:

Establishment Licensing, Billing and Invoicing Unit
Compliance Coordination and Licensing Division
Health Products and Food Branch Inspectorate
Health Canada
250 Lanark Avenue
Ottawa, Ontario K1A 0K9
E-mail: del_questions_leppp@hc-sc.gc.ca
Facsimile: (613) 957-4147
Teletypewriter: 1-800-465-7735 (Service Canada)

2) New: Changes to Calculation of Period of Validity/Expiry for Foreign Site Evidence

Section 3.3 in the document entitled "Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080)" outlines how the period of validity/expiry date for GMP foreign site evidence is calculated and assigned.

GMP Evidence to support foreign sites listed on approved DELs will continue to have a validity period / expiry date. Effective immediately, Health Canada is changing how periods of validity / expiry dates are calculated and assigned to GMP foreign site evidence as currently found in GUI-0080, Section 3.3, Period of validity for Drug GMP compliance evidence of foreign sites.

Section 3.3.1 and 3.3.2 will be adjusted to incorporate the following:

• For sites in a country with which Health Canada has a Mutual Recognition Agreement (MRA) where products and activities (fabrication, packaging, labelling, testing) are covered under the MRA, and for which a Certificate of Compliance (CoC) has been received by the Inspectorate from the Regulatory Authority:
  • The period of validity/expiry date of the CoC is assigned by the Regulatory Authority*, and is normally not more than 3 years from the start date of the inspection.
• For sites not located in a MRA country, or for sites located in a MRA country for products and activities not covered under the MRA:
  • The period of validity or expiry date assigned to GMP foreign sites will be aligned with the start date of the submitted GMP inspection evidence.
  • In most cases, the GMP foreign site evidence will be considered valid for a period of 3* years from the start date of the GMP inspection evidence.

Example:

• The start date of an accepted inspection report is July 15, 2011.Generally, the maximum expiry date* will be July 15, 2014.
• The start date of an accepted inspection report is January 1, 2012. Generally, the maximum expiry date* will be January 1, 2015.

* If a site is assessed as "compliant", a shortened expiry date may be assigned. The following are examples of when this may be applied : the foreign site does not have a strong compliance history ; the foreign site has repeat observations ; the foreign site has been subject to compliance and enforcement actions ; the Inspectorate requires additional information in order to assess the ongoing compliance with the Food and Drug Regulations, Part C, Division 2. In certain and exceptional cases, Health Canada may assign a longer expiry date.

Should you have any questions related to the evidence required to demonstrate GMP compliance of a foreign site or the determination of an expiry for a foreign site, please use the contact information below.

Drug GMP Inspection Unit
Compliance Coordination and Licensing Division
Health Products and Food Branch Inspectorate
Health Canada
250 Lanark Avenue
Ottawa, Ontario  K1A 0K9
E-mail: foreign_site_etranger@hc-sc.gc.ca
Telephone: 613-957-1492
Facsimile: 613-957-6709
Teletypewriter: 1-800-465-7735 (Service Canada)